A Prospective, Randomized Trial to Compare saroGLitazar With pioglitAZone in Nonalcoholic Fatty livEr Disease (GLAZED)
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ClinicalTrials.gov Identifier: NCT02265276 |
Recruitment Status : Unknown
Verified October 2014 by Hari Kumar, Command Hospital, India.
Recruitment status was: Recruiting
First Posted : October 15, 2014
Last Update Posted : October 16, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Fatty Liver | Drug: Saroglitazar Drug: Pioglitazone | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 100 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Treatment |
Official Title: | A Prospective, Randomized Trial to Compare saroGLitazar With pioglitAZone in Nonalcoholic Fatty livEr Disease (GLAZED Trial) |
Study Start Date : | October 2014 |
Estimated Primary Completion Date : | September 2015 |
Estimated Study Completion Date : | September 2015 |
Arm | Intervention/treatment |
---|---|
Active Comparator: Saroglitazar Group
Tab Saroglitazar 4 mg oral daily fixed dose for 24 weeks
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Drug: Saroglitazar
Tab Saroglitazar 4 mg oral daily for 24 weeks
Other Name: Glitazar group |
Placebo Comparator: Pioglitazone Group
Tab Pioglitazone 30 mg daily fixed dose for 24 weeks
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Drug: Pioglitazone
Tab Pioglitazone 30 mg oral daily for 24 weeks
Other Name: Placebo Comparator group |
- Change in the NAFLD fibrosis score [ Time Frame: At baseline and the end of 24 weeks ]
- Change in body composition [ Time Frame: At baseline and the end of 24 weeks ]
- Change in insulin resistance [ Time Frame: At baseline and the end of 24 weeks ]
- Change in lipid profile [ Time Frame: At baseline and the end of 24 weeks ]
- Change in HbA1c [ Time Frame: At baseline and the end of 24 weeks ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Drug naive patients with NAFLD diagnosed on ultrasonography, BMI > 23 kg/m2 and ALT > 1.5 times the upper limit of normal
Exclusion Criteria:
- Use of any drugs other than lifestyle modification for NAFLD, HbA1c > 8% FBS>200, Bilirubin > 1.5 mg/dL
- Any illness likely to cause transaminitis and positive viral markers
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02265276
Contact: Hari Kumar, MD | 00918146141700 | hariendo@rediffmail.com |
India | |
Command Hospital | Recruiting |
Panchkula, Haryana, India, 134107 | |
Contact: JBS Yadava 00911722867534 hariendo@gmail.com |
Principal Investigator: | Hari Kumar, MD | Command Hospital |
Responsible Party: | Hari Kumar, Endocrinologist, Command Hospital, India |
ClinicalTrials.gov Identifier: | NCT02265276 |
Other Study ID Numbers: |
ENDO/2014/4 |
First Posted: | October 15, 2014 Key Record Dates |
Last Update Posted: | October 16, 2014 |
Last Verified: | October 2014 |
NAFLD, Diabetes, Glitazone |
Liver Diseases Fatty Liver Non-alcoholic Fatty Liver Disease Digestive System Diseases |
Pioglitazone Hypoglycemic Agents Physiological Effects of Drugs |